Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury

Official title

Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury: A Hybrid Implementation-Efficacy Trial

Overview

The purpose of this study is to determine the safety and efficacy of Injectrode Tibial Nerve Stimulation for bladder function in people with spinal cord injury.

Interventions

• Device iTNS
  The stimulation current will be gradually increased until bilateral toe flexion is achieved, then reduced to just below the motor contraction threshold. A 20 Hz frequency and 200 µs pulse width will be applied continuously for 30 minutes, five times a week.
• Device Sham iTNS
  The sham devices are designed to mimic active stimulation by initially delivering electrical current sufficient to evoke toe flexion. However, once the current is reduced to the sensory stimulation threshold, the device automatically ramps down to 0mA while maintaining the appearance of normal functioning on the display screen.

Primary outcome measures

• Safety as assessed by the number of device-related adverse events [Time frame: From baseline to 8 weeks]
• Accuracy as assessed by the percentage of sessions where toe flexion was achieved as recorded in subject logs. [Time frame: From baseline to week 8]
• Reliability as assessed by the average minimum current (mA) required to elicit toe flexion when testing for accuracy [Time frame: From baseline to week 8]
• Feasibility of Injectrode procedure as assessed by surveys [Time frame: Week 8]
• Physician acceptability of Injectrode device as assessed by a survey [Time frame: Week 8]
• Participant acceptability of Injectrode device as assessed by a survey [Time frame: Week 8]
• Feasibility and acceptability of the Injectrode treatment as assessed by a qualitative interview [Time frame: Week 8]

Secondary outcome measures (12)

• Number of participants for whom bladder medication dosage reduced [Time frame: from baseline to 8 weeks]
• Change in magnitude of dosage of medication [Time frame: from baseline to 8 weeks]
• Change in bladder function during urodynamics as assessed by the maximum detrusor pressure (Max Pdet) in cmH20. [Time frame: Baseline, Week 4, and Week 8]
• Change in Bladder function as assessed by the presence or absence of detrusor overactivity (DO) during urodynamics. [Time frame: baseline, Week 4, and Week 8]
• Change in bladder capacity (maximum volume in mL) during urodynamics before voiding or discomfort. [Time frame: baseline, Week 4, and Week 8]
• Change in the presence or absence of leaks during urodynamics. [Time frame: baseline, Week 4, and Week 8]
• Change in bladder sensation during urodynamics as defined by the infused volume (mL) at time of reported first sensation of filling. [Time frame: baseline, Week 4, and Week 8]
• Change in bladder sensation during urodynamics as defined by infused volume (mL) at time of reported urgency/ desire to void. [Time frame: Baseline, Week 4, and Week 8]
• Change in bladder sensation during urodynamics as defined by the infused volume (mL) at the time of reported discomfort. [Time frame: Baseline, Week 4, and Week 8]
• Change in detrusor compliance during urodynamics as reported by the change in bladder volume divided by the change in bladder pressure. [Time frame: baseline, Week 4, and Week 8]
• Change in the number of incontinence episodes as self-reported in the bladder diary. [Time frame: Baseline, Week 4, and Week 8]
• Change in the frequency of catheterization as self-reported in the bladder diary. [Time frame: Baseline, Week 4, and Week 8]

Eligibility criteria

Inclusion criteria

• Non-progressive chronic (>1 year) SCI
• Neurologic level of injury T9 and above
• Stable over active bladder (OAB) medications (≥3 months)
• No contraindication to MRI (per MRI Safety Questionnaire)
• English or Spanish speaking
• Tolerate and be able to evoke toe flexion bilaterally with transcutaneous tibial nerve stimulation (tTNS) (self or assisted)
• Pass the tTNS competency checklist to perform or direct performance of tTNS.

Exclusion criteria

• Ongoing/active genitourinary oncologic diagnoses
• History of other central nervous system disorder (CNS) disorders and/or peripheral neuropathy
• Pregnancy or planning to become pregnant.
• Lower Motor Neuron bladder
• Restorative bladder surgery such as augmentation cystoplasty
• Botulinum toxin-A injections in the bladder within 6 months of trial enrolment (injection in other sites is allowed)
• Anticoagulation treatment or prophylaxis
• Advanced peripheral vascular disease (gangrene, amputation, etc.)
• History of intolerance to electrical stimulation, particularly of the leg

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT07264868 · HSC-MS-25-0582 · CDMRP-SC240085

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗